Overview

This trial is active, not recruiting.

Condition metabolic syndrome
Treatments "grab-and-go" meal plan, "jump-start" meal plan
Sponsor University of Missouri-Columbia
Collaborator Robert C. Atkins Foundation
Start date May 2016
End date November 2016
Trial size 20 participants
Trial identifier NCT02774668, 2004733

Summary

The present study is designed to examine the effect of changes in body weight and related parameters associated with a commercially-available, low-carbohydrate diet plan. A parameter proposed to be studied here is the impact of fructose restriction and weight loss on serum uric acid concentrations and arterial stiffness.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose basic science
Arm
(Active Comparator)
The intervention of this arm is to use a "Grab-and-Go" meal plan. This meal plan provides Atkins shakes and bars for breakfast, lunch, and snacks for 2 weeks. For dinner the subject is given a freshly-prepared meal. Upon finishing the 2-week provided food phase, the subject will consume a self-prepared meal of similar nutrient composition at home for another 2 weeks. For the next four weeks while he/she is still enrolled in the study, he/she will have his/her options for food choices which are not controlled for the study.
"grab-and-go" meal plan
The "Grab-and-Go" meal plan will provide Atkins shakes and bars for breakfast, lunch, and snacks. For dinner, the participant will receive a freshly-prepared meal. There will be no difference in terms of calories or nutrient composition between "Grab-and-Go" meal plan versus "Jump-Start" meal plan. The amount of weight loss caused by these two meal plans is not expected to differ.
(Active Comparator)
The intervention of this arm is to use a "Jump Start" meal plan. This meal plan provides Atkins frozen meals at breakfast, lunch and dinner for 2 weeks and these meals are supplemented with fresh salads and vegetables. Upon finishing the 2-week provided food phase, the subject will consume a self-prepared meal of similar nutrient composition at home for another 2 weeks. For the next four weeks while he/she is still enrolled in the study, he/she will have his/her options for food choices which are not controlled for the study.
"jump-start" meal plan
The "Jump-Start" plan will provide Atkins frozen meals at breakfast, lunch and dinner and these meals will be supplemented with fresh salads and vegetables. There will be no difference in terms of calories or nutrient composition between "Grab-and-Go" meal plan versus "Jump-Start" meal plan. The amount of weight loss caused by these two meal plans is not expected to differ.

Primary Outcomes

Measure
Weight loss
time frame: Change of body weight over 4 weeks of dietary intervention and weight variability 2 and 4 weeks after completion of the dietary intervention

Secondary Outcomes

Measure
Arterial Stiffness
time frame: Arterial stiffness will be measured at baseline and 4 weeks
Plasma uric acid level
time frame: Plasma uric acid level will be measured at baseline, 4 weeks and 8 weeks
Plasma fructose level
time frame: Plasma fructose level will be measured at baseline, 4 weeks after finishing the dietary intervention and at 8 weeks upon finishing the study
Acceptability of the meal plan questionnaire
time frame: Questionnaires about acceptability of the meal plan will be administrated at the end of week 2
Food craving questionnaire
time frame: Questionnaires about food cravings will be administrated at baseline visit and 2 weeks after the start of the meal plan

Eligibility Criteria

Male or female participants from 30 years up to 55 years old.

Inclusion Criteria: 1. Men and premenopausal women 2. 30-55 years of age 3. Sedentary lifestyle, defined as less than three sessions of activity per week, or sessions less than 20 minutes per occasion, or less than 5000 steps per day 4. Must be able to speak, read, and write English (due to the small sample size and pilot nature of this study) 5. Overweight/obese subjects with BMI 27.0 - 40.0 kg/m2 and any one of the following characteristics of the metabolic syndrome: A. Serum HDL cholesterol <40 mg/dL (1 mmol/L) in men and <50 mg/dL (1.3 mmol/L) in women B. Blood pressure ≥130/85 mmHg C. Fasting plasma glucose ≥100 mg/dL (5.6 mmol/L) D. Waist circumference in men of >102 cm (40 in) and in women of >88 cm (35 in) E. Serum triglycerides (TG) ≥150 mg/dL (1.7 mmol/L). Exclusion Criteria: 1. Abnormal thyroid function or known liver disease 2. Diabetes or fasting glucose ≥ 125 mg/dL 3. Use of medications that interfere with protein, carbohydrate or lipid metabolism (e.g., fish oil capsules) 4. Occasional or regular tobacco use 5. History of gout 6. Uncontrolled hypertension 7. Pregnant or peri-menopausal 8. Vegetarian food restrictions (the diets consumed contain some meat, eggs and dairy) 9. Alcohol intake: females > 70 g/wk, males >140 g/wk 10. Moderate or vigorous-intensity physical activity, defined as more than 150 minutes per week of moderate-intensity, or 75 minutes a week of vigorous-intensity aerobic physical activity, or an equivalent combination of both.

Additional Information

Official title A Short Term Evaluation of a Structured Weight Loss Plan in Overweight and Obese Adults
Principal investigator Qiong Hu, PhD
Description It is well know that consumption of a calorically-restricted diet helps people lose weight. Such a diet with low carbohydrate lowers the serum uric acid concentration which is a factor associated with obesity and also represents a particular metabolic risk in women compared to men. The present weight loss study will determine whether women benefit more than men to short-term weight loss occurring during restriction of simple sugars. Specifically, this study is designed to cause weight loss acutely through consumption of a diet that is restricted in calorie and simple sugars. Both men and women will be studied and their results compared to determine whether women benefit more with respect to arterial stiffness. Upon finishing the four-week diet intervention, body weight and blood lipids will be assessed two and four weeks later to compare the longer term effect on blood pressure.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Missouri-Columbia.